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The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT04096261
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Sponsor:
Collaborators:
Arda Can Cetindag
Lukas Preis
Information provided by (Responsible Party):
Oliver Peters, Charite University, Berlin, Germany

Brief Summary:
The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Condition or disease Intervention/treatment
Blood Brain Barrier Defect Sleep Deprivation Sleep Apnea Alzheimer Disease Diagnostic Test: Diagnostic Test

Detailed Description:

The aim of our study is the analysis of sleep phases and quality as well as the detection of respiratory pauses in subjects with cognitive disorder. To assess whether sleep quality is associated with the blood-brain barrier and Alzheimer's disease, which may be indicative of an early, non-invasively measurable change in brain activity in the early stages of Alzheimer's disease.

Sleep quality impairment is a known risk factor for memory impairment. There is increasing evidence of a link between measurable sleep parameters, in particular a reduction of slow waves of deep sleep in cognitive deficits. Also, breathing pauses during sleep are associated with increased daytime sleepiness and cognitive impairment. This observational study is intended to establish a possible link between subjective memory disturbances and altered sleep quality or respiratory breaks during sleep. In the run-up to this study, they performed a special MRI scan of the head and a lumbar puncture (removal of nerve water) in a different context. The aim of this imaging study and the new biomarker in brain water was to investigate the function of the blood-brain barrier that occurs in Alzheimer's disease. The results of the studies on the quality of sleep should be evaluated in the context of this study in connection with the findings of the MRI examination and lumbar puncture.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 132 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Days
Official Title: The Importance of Sleep Quality and the Blood-brain Barrier in Cognitive Disorders and Alzheimer's Disease
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy controls
Healthy controls recruited through public advertisement.
Diagnostic Test: Diagnostic Test
Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Siblings of people with Alzheimer's dementia
Siblings of people with Alzheimer's dementia recruited through public advertisement
Diagnostic Test: Diagnostic Test
Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Subjective cognitive decline
Individuals who subjectively experience cognitive decline but do not show deficits in age-, sex- and education-normed neuropsychological test results. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.
Diagnostic Test: Diagnostic Test
Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Mild cognitive impairment
Individuals who show deficits in neuropsychological test procedures but who do not exhibit substantial problems in daily life. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.
Diagnostic Test: Diagnostic Test
Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.

Dementia due to Alzheimer's disease
Individuals diagnosed with dementia due to Alzheimer's disease by relying on anamnesis, neuropsychological test results, results of MRI and biomarkers found in the cerebrospinal fluid. Those individuals are part of the DELCODE cohort and were initially recruited in a memory clinic.
Diagnostic Test: Diagnostic Test
Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.




Primary Outcome Measures :
  1. Marker of blood-brain dysfunction using MRI [ Time Frame: 1 day ]
    Dynamic T1 contrast enhanced sequence using Gadovist

  2. Markers of blood-brain dysfunction using CSF [ Time Frame: 1 day ]
    Platelet-derived growth factor receptor-β in CSF

  3. Sleep quality measurement [ Time Frame: 2 day ]
    Polysomnography


Biospecimen Retention:   Samples Without DNA
Cerebro-spinal fluid


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
A description of the study population is provided by DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).
Criteria
The eligibility criteria are defined by the study protocol from the observational study DZNE - Longitudinal Cognitive Impairment and Dementia Study (DELCODE).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096261


Locations
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Germany
Charité Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Oliver Peters, Prof. Dr.    +49 30 450 517 628    oliver.peters@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Arda Can Cetindag
Lukas Preis

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Responsible Party: Oliver Peters, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04096261    
Other Study ID Numbers: BBB-Sleep
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Sleep Deprivation
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyssomnias
Sleep Wake Disorders
Neurologic Manifestations
Signs and Symptoms